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How Long Should a Lasting Response Last if a Lasting Response
Could Last?
In chronic hepatitis C infection to document spontaneous
remission or response to treatment, more than one parameter is
required, Both the activity of liver disease and of viral
replication need to be recorded, The former is most accurately done
by liver biopsy, The number of such biopsies which a patient or
physician are willing to have performed is necessarily limited,
such that serum-ALT has traditionally been used as surrogate
marker. Viral replication can be quantified using a standardized
and validated polymerase chain reaction (PCR) test system, Drawing
on a database of over 2300 patients with documented chronic
hepatitis C for whom data were recorded longitudinally for up to 5
years, a proposal is presented on how to document more precisely
quality of response and its duration, Using both biochemical and
virological parameters quantified repeatedly at regular intervals,
three response patterns can be described, and less frequent
histological assessments are used for confirmation:
- non-response, where no relevant changes are seen in either
parameter;
- transient response that consists of a response induction,
usually biochemical in nature, accompanied by a transient decrease
in viral replication only. This response is subsequently lost
either during (breakthrough) or after the end of treatment
(relapse);
- finally, a durable response is defined by a rapid return to
normal or fall to undetectable levels, as a rule within 2 weeks to
3 months, of serum ALT and hepatitis C virus (HCV) RNA that is
sustained until the end of the follow-up period (up to 5
years).
Author: RYFF JC, F HOFFMANN LA ROCHE & CO LTD, DEPT CLIN
RES, VIROL SECT, 126 GRENZACHERSTR, CH-4070 BASEL, SWITZERLAND
Source: JOURNAL OF VIRAL HEPATITIS 1997 ;4:95-99
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